Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis

Sponsor

Takeda (Industry)

Overall Status

Completed

CT.gov ID

NCT00471094

Collaborator

(none)

831

Enrollment

Locations

Arms

Duration (Months)

8.8

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to assess the efficacy and safety of 8 weeks of daily treatment with Ilaprazole (5, 20 and 40 mg), once daily (QD), compared to lansoprazole 30 mg in healing subjects with endoscopically proven erosive esophagitis.

Condition or Disease	Intervention/Treatment	Phase
Esophagitis	Drug: Ilaprazole Drug: Ilaprazole Drug: Ilaprazole Drug: Lansoprazole	Phase 2

Detailed Description

This 8 week study will be conducted by approximately 160 investigators in the United States. During this study, esophagitis healing will be evaluated by endoscopy, heartburn and other symptom relief will be evaluated by questionnaire and study drug levels will be measured.

Study Design

Study Type:

Interventional

Actual Enrollment :

831 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

A Phase 2 Study to Evaluate the Safety and Efficacy of Ilaprazole (5 mg QD, 20 mg QD and 40 mg QD) and an Active Comparator, Lansoprazole (30 mg QD) on Healing of Erosive Esophagitis.

Study Start Date :

May 1, 2007

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ilaprazole 5 mg QD	Drug: Ilaprazole Ilaprazole 5 mg, capsules, orally, once daily for up to 8 weeks.
Experimental: Ilaprazole 20 mg QD	Drug: Ilaprazole Ilaprazole 20 mg, capsules, orally, once daily for up to 8 weeks.
Experimental: Ilaprazole 40 mg QD	Drug: Ilaprazole Ilaprazole 40 mg, capsules, orally, once daily for up to 8 weeks.
Active Comparator: Lansoprazole 30 mg QD	Drug: Lansoprazole Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.

Outcome Measures

Primary Outcome Measures

The crude healing rate of Erosive Esophagitis at week 4 of treatment as assessed by endoscopy. [Week 4]

Secondary Outcome Measures

The crude healing rate of Erosive Esophagitis at week 8 of treatment as assessed by endoscopy. [Week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Subject must have endoscopically confirmed erosive esophagitis as defined by the Los Angeles (LA) Classification Grading System (A-D).

Exclusion Criteria:

Evidence of uncontrolled, clinically significant systemic disease; acquired immunodeficiency syndrome (AIDs); a condition likely to require surgery; cancer within 5 years of screening; or abnormal laboratory values.
Co-existing diseases affecting the esophagus; history of esophageal radiation therapy, cryotherapy, or physiochemical trauma.
History of esophageal surgery or dilatation of an esophageal stricture other than Schatzki's ring; gastric or duodenal surgery except simple oversew of an ulcer.
Active gastric or duodenal ulcers or acute upper gastrointestinal hemorrhage within 30 days prior to screening.
Current or history of Zollinger-Ellison syndrome or other hypersecretory conditions.
Allergy to any proton pump inhibitor drug (omeprazole, lansoprazole, pantoprazole, rabeprazole, esomeprazole), any component of Ilaprazole, or antacid.
Unable to tolerate lactose.
Use of the following medications prior to randomization or anticipated use during the study: proton pump inhibitors, antacids, biphosphonates, histamine (H2) receptor antagonist (examples: Zantac, Tagamet), sucralfate, misoprostol, corticosteroids, prokinetics, Non-steroidal anti-inflammatory drugs (NSAIDs), strong anticholinergics, anticoagulant/anti-platelet aggregate therapy, anticoagulants, digoxin, theophylline, phenytoin.
History of alcoholism or drug addiction.

Contacts and Locations

Locations

	City	State	Country
1	Hueytown	Alabama	United States
2	Huntsville	Alabama	United States
3	Chandler	Arizona	United States
4	Phoenix	Arizona	United States
5	Tempe	Arizona	United States
6	Tucson	Arizona	United States
7	Sherwood	Arkansas	United States
8	Anaheim	California	United States
9	Cypress	California	United States
10	Encinitas	California	United States
11	Garden Grove	California	United States
12	Irvine	California	United States
13	Lancaster	California	United States
14	Mission Hills	California	United States
15	Oakland	California	United States
16	Orange	California	United States
17	Pasadena	California	United States
18	San Diego	California	United States
19	West Covina	California	United States
20	Colorado Springs	Colorado	United States
21	Longmont	Colorado	United States
22	Pueblo	Colorado	United States
23	Bristol	Connecticut	United States
24	Washington	District of Columbia	United States
25	Longwood	Florida	United States
26	Miami	Florida	United States
27	New Smyrna Beach	Florida	United States
28	Pembroke Pines	Florida	United States
29	Tampa	Florida	United States
30	Zephyrhills	Florida	United States
31	Atlanta	Georgia	United States
32	Conyers	Georgia	United States
33	Newnan	Georgia	United States
34	Tucker	Georgia	United States
35	Boise	Idaho	United States
36	Moline	Illinois	United States
37	Rockford	Illinois	United States
38	Clive	Iowa	United States
39	Davenport	Iowa	United States
40	Dubuque	Iowa	United States
41	Wichita	Kansas	United States
42	Metairie	Louisiana	United States
43	Chevy Chase	Maryland	United States
44	Prince Frederick	Maryland	United States
45	Olive Branch	Mississippi	United States
46	Jefferson City	Missouri	United States
47	Kansas City	Missouri	United States
48	Mexico	Missouri	United States
49	Egg Harbor Township	New Jersey	United States
50	Albuquerque	New Mexico	United States
51	Binghamton	New York	United States
52	Great Neck	New York	United States
53	Rochester	New York	United States
54	Chapel Hill	North Carolina	United States
55	Fayetteville	North Carolina	United States
56	Greensboro	North Carolina	United States
57	Raleigh	North Carolina	United States
58	Wilmington	North Carolina	United States
59	Winston-Salem	North Carolina	United States
60	Cincinnati	Ohio	United States
61	Dayton	Ohio	United States
62	Norman	Oklahoma	United States
63	Oklahoma City	Oklahoma	United States
64	Medford	Oregon	United States
65	Portland	Oregon	United States
66	Beaver Falls	Pennsylvania	United States
67	Harrisburg	Pennsylvania	United States
68	Lansdale	Pennsylvania	United States
69	Warwick	Rhode Island	United States
70	Anderson	South Carolina	United States
71	Charleston	South Carolina	United States
72	Goose Creek	South Carolina	United States
73	Mt. Pleasant	South Carolina	United States
74	Sioux Falls	South Dakota	United States
75	Bristol	Tennessee	United States
76	Chattanooga	Tennessee	United States
77	Johnson City	Tennessee	United States
78	Nashville	Tennessee	United States
79	Amarillo	Texas	United States
80	Austin	Texas	United States
81	Beaumont	Texas	United States
82	Bryan	Texas	United States
83	El Paso	Texas	United States
84	Fort Worth	Texas	United States
85	Houston	Texas	United States
86	Odessa	Texas	United States
87	San Antonio	Texas	United States
88	Midvale	Utah	United States
89	Ogden	Utah	United States
90	Newport News	Virginia	United States
91	Norfolk	Virginia	United States
92	Spokane	Washington	United States
93	Milwaukee	Wisconsin	United States
94	Monroe	Wisconsin	United States